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Monoclonal Antibodies

Phase II: Valemetostat + Atezolizumab 1200 mg + Bevacizumab 15 mg/kg for Liver Cancer

Phase 1 & 2

Waitlist Available

Led By Mehmet S Akce, MD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 48 months

Awards & highlights

Study Summary

This trial is testing a new combination treatment for advanced liver cancer patients who have not received prior systemic therapy. The treatment includes valemetostat, atezolizumab, and bevaciz

Who is the study for?

This trial is for adults with advanced Hepatocellular carcinoma (HCC) who haven't had systemic therapy for their condition. Details on specific inclusion and exclusion criteria are not provided, but typically participants need to meet certain health standards.Check my eligibility

What is being tested?

The study tests valemetostat combined with atezolizumab and bevacizumab in treating liver cancer. It's a two-part trial: first, finding the right dose of valemetostat (dose escalation), then seeing how well it works at that dose (dose expansion).See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones for cancer treatments like these may include fatigue, nausea, increased risk of infection, bleeding issues due to bevacizumab, and possible immune-related reactions from atezolizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Phase 1b

Phase II

Secondary outcome measures

Disease Control Rate (DCR)

Duration of response (DoR)

Overall survival (OS)

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Phase II: Valemetostat + Atezolizumab 1200 mg + Bevacizumab 15 mg/kgExperimental Treatment3 Interventions

During Phase II, study participants will receive valemetostat (DS-3201) orally daily at MTD/RP2D, plus atezolizumab 1200 mg intravenously (IV) on day 1, and bevacizumab 15 mg/kg IV on day 1 of each cycle.

Group II: Phase 1b: Valemetostat + Atezolizumab 1200 mg + Bevacizumab 15 mg/kgExperimental Treatment3 Interventions

In Phase 1b patients will receive valemetostat (DS-3201) orally daily at their assigned dose level, plus atezolizumab 1200 mg intravenously (IV) on day 1, and bevacizumab 15 mg/kg IV on day 1 of each cycle. During Phase 1b, a 3+3 dose escalation design will be utilized to define the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) with starting dose of valemetostat 150mg by mouth daily.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

Atezolizumab

2017

Completed Phase 3

~5860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor

1,583 Previous Clinical Trials

2,279,999 Total Patients Enrolled

1 Trials studying Liver Cancer

5 Patients Enrolled for Liver Cancer

Mehmet S Akce, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current opportunities for individuals to enroll in this research study?

"Per clinicaltrials.gov data, this particular research endeavor is presently not open for enrollment. Despite being last updated on February 28th, 2024 and initially posted on May 31st of the same year, it currently does not seek participants. However, there are a substantial number of 2653 alternative studies actively enrolling individuals at present."

Answered by AI

What is the primary objective that this medical study aims to achieve?

"The main objective of this clinical study, to be assessed over a baseline period spanning up to 36 months, is Phase 1b. Additional objectives include Safety and pharmacokinetics (PK), which aims at analyzing the safety and PK profile of valemetostat combined with atezolizumab and bevacizumab; Progression-free survival (PFS) aiming to calculate PFS for valemetostat when used alongside atezolizumab and bevacizumab in advanced HCC; Duration of response (DoR) estimating the duration of response for valemetostat when administered along with at"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC

Mehmet Akce, MD 2024. "A Study of Valemetostat Tosylate (DS-3201b) With Atezolizumab and Bevacizumab in HCC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06294548.